A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit

A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit - A randomized phase II study of apreipitant in women younger than 70 years without alcohol drinking habit

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004998

Enrollment

Registered

2011-02-01

Start date

2011-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female cancer patients younger than 70 years without alcohol drinking habit

Interventions

Aprepitant arm: day 1, aprepitant 125 mg, granisetron 1 mg, and dexamethasone 12 mg before chemotherapy

days 2 through 3, aprepitant 80 mg qd and dexamethasone 4 mg qd Control arm: day 1, granisetron 1 mg and dexamethasone 20 mg before chemotherapy

days 2 through 3, dexamethasone 8 mg qd

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Eligible women younger than 70 years old without alcohol drinking habi, na&iuml;ve to APR with lung, colorectal, gynecologic or primary unknown cancer are treated with carboplatin (AUC 5-6) or irinotecan (more than 150 mg/m2) based regimens.

Exclusion criteria

Exclusion criteria: Any anthracylin and cyclophosphamide (AC) regimens are not permitted.

Design outcomes

Primary

Measure	Time frame
the proportion of patients with complete response (CR), defined as no vomiting and no use of rescue therapy, during 120 h after initiation of chemotherapy in cycle 1	—

Secondary

Measure	Time frame
The key secondary objectives are proportions of women with no vomiting with rescue use, or with total control (no nausea, no vomiting and no rescue use) during the 120 h post-chemotherapy.	—

Countries

Japan

Contacts

Public ContactMaki Tanioka

Hyogo Cancer Center Medical oncology

tanioka@hp.pref.hyogo.jp078-929-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026